Technology Strategist

RoKey Responsibilities

1. Digital and Technology Strategy

• Develop and execute the CROs multi-year technology roadmap aligned with business growth and operational goals.
• Evaluate emerging technologies (AI/ML, automation, data analytics, cloud computing, eTMF, EDC, LIMS, CTMS, etc.) for their relevance and ROI.
• Align technology initiatives with regulatory, clinical, and client-driven requirements.
• Act as the technology advisor to the leadership team for digital transformation and innovation.

2. Systems Architecture and Integration

• Oversee the architecture, selection, and integration of core CRO systems (CTMS, EDC, LIMS, pharmacovigilance, regulatory, QA, and ERP tools).
• Ensure interoperability between platforms (e.g., linking clinical data with regulatory submissions, QA, and finance).
• Champion data standardization, system validation, and secure APIs for cross-functional efficiency.
• Collaborate with vendors, IT teams, and clinical operations to ensure seamless technology adoption.

3. Data Strategy and Governance

• Develop and maintain the organization’s data strategy, including data integrity, privacy, and compliance (21 CFR Part 11, GDPR, HIPAA).
• Define policies for data storage, retention, and access across projects and geographies.
• Implement data lakes or centralized repositories for advanced analytics and real-time reporting.
• Support AI/ML use cases for trial modeling, predictive enrollment, and risk-based monitoring.

4. Automation and Process Optimization

• Identify manual or paper-heavy workflows suitable for automation (clinical operations, regulatory tracking, finance, HR, QA).
• Lead implementation of RPA (Robotic Process Automation), workflow tools, and low-code platforms.
• Quantify efficiency gains and track ROI of automation initiatives.
• Ensure validation and compliance of automated systems under GxP guidelines.

5. IT Infrastructure and Cybersecurity Oversight

• Ensure robust, scalable, and secure IT infrastructure to support multi-country operations and remote teams.
• Collaborate with IT and QA to enforce cybersecurity, data privacy, and system backup policies.
• Oversee vendor assessments and periodic technology audits for compliance.
• Ensure disaster recovery, business continuity, and cloud service governance.

6. Cross-Functional Collaboration

• Partner with heads of Clinical Operations, Biometrics, Regulatory Affairs, Quality Assurance, and Finance to align tech systems with process needs.
• Work with BD and client services teams to demonstrate the CRO’s digital capabilities to sponsors.
• Drive digital training programs to upskill teams and ensure adoption.
• Develop and manage external partnerships with technology providers.

7. Strategic Planning and Innovation

• Benchmark CRO technology landscape against industry leaders.
• Lead feasibility studies and pilots for new digital capabilities (e.g., decentralized trials, ePRO/eCOA, AI-driven risk-based monitoring).
• Present business cases and ROI models to the leadership and board.
• Represent the CRO at technology forums, client meetings, and industry events.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Information Systems, Bioinformatics, or related field.
• 10–15 years of experience in technology management, with at least 5 years in pharma/CRO/life sciences.
• Proven track record in implementing and managing enterprise systems such as CTMS, EDC, eTMF, or ERP.
• Strong understanding of GxP, 21 CFR Part 11, data integrity, and IT validation principles.
• Experience with automation, analytics, and AI/ML in a regulated environment is highly desirable.
• Excellent leadership, vendor management, and communication skills.